Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

LZA 2021-05-07

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)

Applicant Meditech Gloves Sdn Bhd

K-Number K210755

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JDR 2021-05-07

FuseForce™ Flex Dynamic Compression System

Applicant Wright Medical

K-Number K203832

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JOW 2021-05-07

Reprocessed Tri Pulse Compression Garment

Applicant Renu Medical, Inc.

K-Number K203847

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LLZ 2021-05-06

ImagePilot

Applicant Konica Minolta, Inc.

K-Number K210066

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GEI 2021-05-06

CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)

Applicant Bolder Surgical, LLC

K-Number K203183

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GEH 2021-05-06

Dr. Yglo Wart Remover

Applicant Theotclab Healthcare B.V.

K-Number K210529

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GEI 2021-05-06

CoolSeal Reveal

Applicant Bolder Surgical, LLC

K-Number K203640

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KPE 2021-05-06

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL

Applicant Gilero, LLC

K-Number K201936

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JWH 2021-05-06

Identity Imprint Knee Replacement System

Applicant Conformis, Inc.

K-Number K210191

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IPF 2021-05-06

Talent-Pro Electromagnetic Stimulator

Applicant Remed Co., Ltd.

K-Number K202031

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FOS 2021-05-06

Umbilical Vessels Catheter

Applicant Haolang Medical USA Corporation

K-Number K201697

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FXX 2021-05-06

3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3

Applicant 3A Medical Products Co., Ltd.

K-Number K202598

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